Latest news with #Shalev
Yahoo
29-05-2025
- Business
- Yahoo
TIXiMED Announces Successful Completion of a Phase 1 Study of its Novel Oral Disease-Modifying Type 1 Diabetes Therapy
TIX100 Demonstrates Safety and Tolerability in Human Subjects, Marking a Key Drug Development Milestone Post-Hoc Analysis Reveals Promising First Biological TIX100 Signal in Humans TIXiMED to Advance TIX100 to Multiple Ascending Dose Studies BIRMINGHAM, Ala., May 29, 2025--(BUSINESS WIRE)--TIXiMED, Inc. ( a clinical-stage pharmaceutical company developing a novel disease-modifying oral therapy for type 1 diabetes (T1D), today announced the successful completion of the Phase 1 Single Ascending Dose (SAD) study for TIX100. This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post-hoc analysis revealed decreased postprandial blood glucose excursion and improved glucose homeostasis after a standardized liquid meal in the two highest dose cohorts, providing the first evidence of a biological TIX100 effect in humans. "We are thrilled with the successful completion of the Phase 1 SAD study, which demonstrated the safety and tolerability of TIX100 in humans," said Dr. Anath Shalev, Founder and Chief Scientific Officer at TIXiMED. "We are also excited that, despite the small sample size and healthy study population, a promising metabolic TIX100 signal became evident at the human dose predicted in preclinical models," Dr. Shalev added. "These findings also suggest that stronger effects might be observed in people with diabetes and bring TIXiMED closer to delivering a novel oral therapy that addresses the underlying causes of T1D, offering hope for improved outcomes for patients across all stages of the disease." This double-blind, randomized, placebo-controlled Phase 1 SAD study evaluated the safety, tolerability, and pharmacokinetics of TIX100 at escalating doses in 28 healthy adults. Clinical and laboratory results demonstrated no drug-related adverse events, no ECG changes and no hypoglycemia with TIX100 exhibiting a favorable safety profile and predictable pharmacokinetics, supporting progression to the next phase of clinical development. TIX100 is an oral drug that targets thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in people with diabetes and leads to beta cell death and pancreatic islet dysfunction. TXNIP inhibition has been demonstrated in mouse models and in humans with T1D to protect the body's own insulin-producing beta cells while promoting overall islet cell health. TIX100 has also been shown to reduce unnecessary glucose production from the liver. TIX100 is a potent and specific TXNIP inhibitor designed to target these underlying disease mechanisms and has been shown to be highly efficacious in preventing and reversing diabetes in pre-clinical studies. Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose (MAD) study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects. "Clinical advancement of innovative therapies addressing the fundamental biological causes of T1D is exciting, and supporting these efforts is critical to preventing and delaying T1D disease progression," says Dr. Ben Williams, Program Officer at The Leona M. and Harry B. Helmsley Charitable Trust. "The unique target product profile and mechanism of TIX100 positions it as a promising candidate to transform T1D management," said Steve Daly, CEO of TIXiMED. "We are inspired by these results and excited to advance to the MAD study, continuing our mission to address the unmet needs of people living with T1D." About TIXiMED TIXiMED is a pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on inhibition of the protein TXNIP. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, which has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit for more information. The Helmsley Charitable Trust made a Program Related Investment in the form of a loan to support this project. View source version on Contacts Emma BoldenEmail: Emma@ Phone: +1.949.939.8771Website: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
29-05-2025
- Health
- Business Wire
TIXiMED Announces Successful Completion of a Phase 1 Study of its Novel Oral Disease-Modifying Type 1 Diabetes Therapy
BIRMINGHAM, Ala.--(BUSINESS WIRE)-- TIXiMED, Inc. ( a clinical-stage pharmaceutical company developing a novel disease-modifying oral therapy for type 1 diabetes (T1D), today announced the successful completion of the Phase 1 Single Ascending Dose (SAD) study for TIX100. This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post-hoc analysis revealed decreased postprandial blood glucose excursion and improved glucose homeostasis after a standardized liquid meal in the two highest dose cohorts, providing the first evidence of a biological TIX100 effect in humans. Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects. Share 'We are thrilled with the successful completion of the Phase 1 SAD study, which demonstrated the safety and tolerability of TIX100 in humans,' said Dr. Anath Shalev, Founder and Chief Scientific Officer at TIXiMED. 'We are also excited that, despite the small sample size and healthy study population, a promising metabolic TIX100 signal became evident at the human dose predicted in preclinical models,' Dr. Shalev added. 'These findings also suggest that stronger effects might be observed in people with diabetes and bring TIXiMED closer to delivering a novel oral therapy that addresses the underlying causes of T1D, offering hope for improved outcomes for patients across all stages of the disease.' This double-blind, randomized, placebo-controlled Phase 1 SAD study evaluated the safety, tolerability, and pharmacokinetics of TIX100 at escalating doses in 28 healthy adults. Clinical and laboratory results demonstrated no drug-related adverse events, no ECG changes and no hypoglycemia with TIX100 exhibiting a favorable safety profile and predictable pharmacokinetics, supporting progression to the next phase of clinical development. TIX100 is an oral drug that targets thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in people with diabetes and leads to beta cell death and pancreatic islet dysfunction. TXNIP inhibition has been demonstrated in mouse models and in humans with T1D to protect the body's own insulin-producing beta cells while promoting overall islet cell health. TIX100 has also been shown to reduce unnecessary glucose production from the liver. TIX100 is a potent and specific TXNIP inhibitor designed to target these underlying disease mechanisms and has been shown to be highly efficacious in preventing and reversing diabetes in pre-clinical studies. Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose (MAD) study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects. 'Clinical advancement of innovative therapies addressing the fundamental biological causes of T1D is exciting, and supporting these efforts is critical to preventing and delaying T1D disease progression,' says Dr. Ben Williams, Program Officer at The Leona M. and Harry B. Helmsley Charitable Trust. 'The unique target product profile and mechanism of TIX100 positions it as a promising candidate to transform T1D management,' said Steve Daly, CEO of TIXiMED. 'We are inspired by these results and excited to advance to the MAD study, continuing our mission to address the unmet needs of people living with T1D.' About TIXiMED TIXiMED is a pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on inhibition of the protein TXNIP. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, which has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit for more information. The Helmsley Charitable Trust made a Program Related Investment in the form of a loan to support this project.
Yahoo
29-05-2025
- Business
- Yahoo
TIXiMED Announces Successful Completion of a Phase 1 Study of its Novel Oral Disease-Modifying Type 1 Diabetes Therapy
TIX100 Demonstrates Safety and Tolerability in Human Subjects, Marking a Key Drug Development Milestone Post-Hoc Analysis Reveals Promising First Biological TIX100 Signal in Humans TIXiMED to Advance TIX100 to Multiple Ascending Dose Studies BIRMINGHAM, Ala., May 29, 2025--(BUSINESS WIRE)--TIXiMED, Inc. ( a clinical-stage pharmaceutical company developing a novel disease-modifying oral therapy for type 1 diabetes (T1D), today announced the successful completion of the Phase 1 Single Ascending Dose (SAD) study for TIX100. This first human trial confirmed that TIX100 was safe and well-tolerated across all tested dose levels in healthy subjects. Additionally, post-hoc analysis revealed decreased postprandial blood glucose excursion and improved glucose homeostasis after a standardized liquid meal in the two highest dose cohorts, providing the first evidence of a biological TIX100 effect in humans. "We are thrilled with the successful completion of the Phase 1 SAD study, which demonstrated the safety and tolerability of TIX100 in humans," said Dr. Anath Shalev, Founder and Chief Scientific Officer at TIXiMED. "We are also excited that, despite the small sample size and healthy study population, a promising metabolic TIX100 signal became evident at the human dose predicted in preclinical models," Dr. Shalev added. "These findings also suggest that stronger effects might be observed in people with diabetes and bring TIXiMED closer to delivering a novel oral therapy that addresses the underlying causes of T1D, offering hope for improved outcomes for patients across all stages of the disease." This double-blind, randomized, placebo-controlled Phase 1 SAD study evaluated the safety, tolerability, and pharmacokinetics of TIX100 at escalating doses in 28 healthy adults. Clinical and laboratory results demonstrated no drug-related adverse events, no ECG changes and no hypoglycemia with TIX100 exhibiting a favorable safety profile and predictable pharmacokinetics, supporting progression to the next phase of clinical development. TIX100 is an oral drug that targets thioredoxin-interacting protein (TXNIP), a detrimental protein that is elevated in people with diabetes and leads to beta cell death and pancreatic islet dysfunction. TXNIP inhibition has been demonstrated in mouse models and in humans with T1D to protect the body's own insulin-producing beta cells while promoting overall islet cell health. TIX100 has also been shown to reduce unnecessary glucose production from the liver. TIX100 is a potent and specific TXNIP inhibitor designed to target these underlying disease mechanisms and has been shown to be highly efficacious in preventing and reversing diabetes in pre-clinical studies. Building on these results, TIXiMED is now preparing to initiate a Phase 1 Multiple Ascending Dose (MAD) study to further assess longer-term TIX100 safety, tolerability, and pharmacokinetics over multiple doses in healthy subjects. "Clinical advancement of innovative therapies addressing the fundamental biological causes of T1D is exciting, and supporting these efforts is critical to preventing and delaying T1D disease progression," says Dr. Ben Williams, Program Officer at The Leona M. and Harry B. Helmsley Charitable Trust. "The unique target product profile and mechanism of TIX100 positions it as a promising candidate to transform T1D management," said Steve Daly, CEO of TIXiMED. "We are inspired by these results and excited to advance to the MAD study, continuing our mission to address the unmet needs of people living with T1D." About TIXiMED TIXiMED is a pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on inhibition of the protein TXNIP. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, which has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit for more information. The Helmsley Charitable Trust made a Program Related Investment in the form of a loan to support this project. View source version on Contacts Emma BoldenEmail: Emma@ Phone: +1.949.939.8771Website: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Times
05-05-2025
- Business
- Business Times
Singapore's AI large language model Sea-Lion to offer more features as more firms use it in S-E Asia
[SINGAPORE] Singapore's home-grown large language model (LLM), Sea-Lion, is steadily gaining traction, with some 235,000 downloads so far, bolstered by adoption by large companies such as GoTo Group in Indonesia. After releasing the latest model with 'reasoning' capabilities on Apr 15, its researchers at AI Singapore told The Straits Times that they plan to add voice recognition later in 2025, followed by other modalities such as visual recognition. The new features are expected to enhance the model's usability in a region rich in spoken and unwritten languages. The model currently recognises 13 languages, including Javanese, Sudanese, Malay, Tamil, Thai and Vietnamese, as well as English and Chinese. Sea-Lion is already tapped by some businesses for its language features, with GoTo among the first enterprises to adopt Sea-Lion in February 2024 as a base to build its own artificial intelligence (AI) system. Its chief data officer, Ofir Shalev, noted: 'Training a model from scratch is often prohibitively expensive. So like many in the industry, we adopted a continuous pre-training approach – building on an existing model as the starting point.' GoTo's Sahabat-AI model is now benchmarked as more accurate in reading and interpreting Bahasa Indonesia, Javanese and Sundanese than other models of similar size, according to Shalev. A NEWSLETTER FOR YOU Friday, 8.30 am Asean Business Business insights centering on South-east Asia's fast-growing economies. Sign Up Sign Up The S$70 million Sea-Lion initiative to build an open-source LLM that reflects the native characteristics of South-east Asia was publicly launched in December 2023. It is funded by the National Research Foundation and backed by the Infocomm Media Development Authority and Agency for Science, Technology and Research. Sea-Lion's latest iteration v3.5, built on another open-source model, Llama 3.1, is fine-tuned to be more adept at complex problem-solving, logical inference and multi-step instructions than earlier versions. It is one of the few models worldwide to offer a 'hybrid reasoning' mode, allowing users to toggle advanced reasoning on or off – saving time and computing resources for straightforward tasks. A key improvement is the model's 128,000-token context window, enabling it to process and understand much longer documents and conversations without losing track of earlier information. This is on a par with leading models such as GPT-4o and Meta's Llama 3.1, and surpassed by only a few, such as Google's Gemini and Anthropic's Claude. The chief scientist at Singtel technology subsidiary NCS, Ying Shaowei, calls Sea-Lion v3.5 a significant advancement for Singapore's AI ecosystem. NCS is expanding its Sea-Lion pilot to support legal and compliance document translation. It will use the latest model to also perform multilingual customer engagement and cross-border regulatory change detection, and to unify internal content across languages and formats. Ying said: 'We are deeply interested in how well the model performs as part of a larger system, how it integrates with existing enterprise workflows, its interoperability, its total cost of deployment and its security posture.' Dr Leslie Teo (centre), senior director of AI products and the Sea-Lion team's lead, with the rest of the team at AI Singapore. The model currently recognises 13 languages, including Javanese, Sudanese, Malay, Tamil, Thai and Vietnamese, as well as English and Chinese. PHOTO: HESTER TAN, ST These critical factors will determine if Sea-Lion can be scaled up in real operational environments, Ying said. He added: 'Sea-Lion is showing real promise on several of these fronts, and we are continuing to test its role in more complex AI-driven solutions that go beyond language to include insight extraction, document classification and voice-based interaction.' In Thailand, Sea-Lion has been adopted into a voice app that, in one instance, helped a Bahasa Indonesia-speaking worker file a complaint with the Labour Department to recoup her unpaid salary. The complaint was filed in Thai. Its other use cases include a Python programming script that recognises the unique Thai calendar system of adding 543 years to the Gregorian year. It also recommended Asian condiments for cooking to a Filipino-speaking user. Dr Ngui Jian Gang, who demonstrated the model to The Straits Times, said: 'GPT 4 recommends mayonnaise, which is not very local, and also lemon butter sauce, which is delicious, but also not very local.' Dr Leslie Teo, senior director of AI products and the Sea-Lion team's lead at AI Singapore, said when evaluated against an industry benchmark tailored for the region, Sea-Lion v3.5 outperformed ChatGPT's and Deepseek's recent models. The benchmark called SEA-Helm – the South-east Asian Holistic Evaluation of Language Models – is developed by AI Singapore in partnership with Stanford University's Centre for Research on Foundation Models. The evaluation was done across five metrics – comprising natural language processing, instruction-following, conversational ability, linguistic and cultural performance, and toxicity detection for low-resource South-east Asian languages. Dr Teo describes Sea-Lion as best used as a 'small model' for simple tasks, or as a 'companion model' paired with large models such as ChatGPT, Claude or DeepSeek to fill gaps in the South-east Asian context. He hopes that it will be useful for organisations with operations in the region. With the new and planned improvements, he is hopeful of drawing more adopters. He said: 'What has changed this time is that performance is close to the frontier.' The Sea-Lion ecosystem is also ready, he added. An interactive web platform called Playground lets users try out the model; its Telegram bot allows users to engage it in their preferred language; and it has application programming interfaces that enable developers and organisations to integrate Sea-Lion into their applications and workflows. Dr Teo said: 'We feel that the model is good enough. We want people to use it more. We want to get to a point where we have real big users using it, criticising it and helping us make it better.' THE STRAITS TIMES
Associated Press
08-03-2025
- Business
- Associated Press
TIXiMED Inc. Announces Successful Dosing of First Cohort in the Phase 1 Clinical Trial of TIX100, its Investigational Disease-Modifying Treatment for Type 1 Diabetes
TIXiMED Inc. ( a clinical-stage pharmaceutical company based on the breakthrough discovery that TXNIP plays an important role in the development and progression of diabetes, today announced successful dosing of the first dose cohort in the Phase 1 Single Ascending Dose (SAD) trial of TIX100, its investigational novel oral therapy targeting beta cell health and islet cell function. Additionally, based on the safety review meeting, it was recommended that the randomized, placebo-controlled quadruple-blind clinical trial continue with no modifications and the next cohort escalate to the pre-specified dose level. ' We are pleased to achieve this significant milestone in the development of TIX100 with this first-in-human trial,' said Dr. Anath Shalev, TIXiMED Founder and Chief Scientific Officer. ' We look forward to evaluating the findings of the next, higher dose cohorts in the coming months and to a successful completion of the SAD trial later this year,' Dr. Shalev added. ' We have seen increasing recognition of the promise of TIX100 to one day improve the lives of people with type 1 diabetes,' said TIXiMED President and Board Chair Mike Goodrich. ' This first-in-human trial is the cornerstone of the clinical work we've planned to advance this novel therapy. We are very thankful to our investors and partners, including The Helmsley Charitable Trust, who made a program-related investment in the form of a loan to TIXiMED,' Mr. Goodrich concluded. About TIXiMED Inc. TIXiMED is a clinical stage pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on TXNIP inhibition. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, that has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit for more information. +1.205.578.1005 SOURCE: TIXiMED Inc. Copyright Business Wire 2025. PUB: 03/07/2025 09:00 PM/DISC: 03/07/2025 09:00 PM
